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Abstract Details

XEN1101, a Novel Potassium Channel Modulator: Interim Data From an Ongoing, Long-Term, Open-Label Extension of a Phase 2b study (X-TOLE) in Adults with Focal Epilepsy
S44 - Epilepsy/Clinical Neurophysiology (EEG): Epilepsy Outcomes
XEN1101 is a novel, potent, selective Kv7.2/7.3 potassium channel opener shown to be effective in a randomized, double-blind, placebo-controlled Phase 2b study in patients with focal onset seizures (FOS). We now report long-term outcomes from the X-TOLE open-label extension (OLE).
Report interim data from an ongoing, long-term, open-label extension of a phase 2b study (X-TOLE) of XEN1101 in adults with focal epilepsy.
After the double-blind period (DBP), eligible patients began the OLE at 20 mg QD in the fed state. Safety was assessed as severity and frequency of treatment emergent adverse events (TEAEs) and serious AEs (SAE), clinically significant changes in laboratory findings and other measures. The primary efficacy outcome was median percent change in monthly FOS frequency from DBP baseline and monthly response rate (≥50% reduction from DBP baseline in monthly FOS frequency).
Of the 285 subjects completing the DBP, 275 (96.5%) entered the OLE. In this interim analysis of the ongoing OLE, the retention rate at 1 year was 68%.   The most common TEAEs were dizziness, headache, somnolence, weight increased, fall, gait disturbance, fatigue, confusional state, aphasia, and memory impairment. No TEAEs of pigmentary abnormalities were reported. Two patients experienced TEAEs of urinary retention (1 mild, 1 moderate, possibly drug related, but both patients continued the medication). The average (mean ± SD) weight gain at the 6-month visit was 1.4 ± 4.5 kg. Updated safety and efficacy analyses will be presented.
In the X-TOLE OLE, XEN1101 20 mg was generally well-tolerated and demonstrated a safety profile similar to the DBP and other anti-seizure medicines used in patients with focal epilepsy; no new safety signals emerged.
Authors/Disclosures
Jacqueline French, MD, FAAN (NYU Comprehensive Epilepsy Ctr)
PRESENTER 		The institution of Dr. French has received research support from Epilepsy Study Consortium/ Epilepsy Foundation (Funded by UCB). The institution of Dr. French has received research support from GW/One8 Foundation/FACES. The institution of Dr. French has received research support from NINDS. The institution of Dr. French has received research support from Xenon. The institution of Dr. French has received research support from Cerevel. The institution of Dr. French has received research support from FACES. The institution of Dr. French has received research support from UCB. The institution of Dr. French has received research support from Epilepsy Study Consortium. The institution of Dr. French has received research support from UCB. Dr. French has received personal compensation in the range of $100,000-$499,999 for serving as a Chief Medical/Innovation Officer with Epilepsy Foundation. Dr. French has a non-compensated relationship as a Consultant with Angelini that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Alterity Therapeutics Limited that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Bright minds Biosciences that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cerecin Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cognizance Biomarkers that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Arvelle that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Beacon biosignals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Biogen that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Biohaven Pharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with BioMarin Pharmaceutical Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with BioXcel Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Bloom Science Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with BridgeBio Pharma Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Camp4 Therapeutics Corporation that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cerebral Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cerevel that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a SAB with Clinical Education Alliance that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a SAB with Coda Biotherapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Genentech Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Crossject that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Eisai, that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Eliem Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Encoded Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with iQure Pharma that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Engrail that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Epalex that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a SAB with Epihunter that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a SAB with Epiminder that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Epitel Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Equilibre BioPharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Greenwich Biosciences that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Grin Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with GW Pharma that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Janssen Pharmaceutica that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Jazz Pharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Knopp Biosciences that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Lipocine that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with LivaNova that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Longboard Pharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Lundbeck that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Marinus that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Modulight Bio that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Leal therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neumirna Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant,SAB with Neurocrine that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neuroelectrics USA Corporation that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Neurelis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neuronetics Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Ono Pharmaceutical Co that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Otsuka Pharmaceutical Development that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Ovid Therapeutics Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Paladin Labs Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Rapport Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Pfizer that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Praxis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with PureTech LTY Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Rafa Laboratories Ltd that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with SK Life Sciences that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Sofinnova that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Stoke that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Supernus that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Synergia Medica that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Takeda that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with UCB Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Ventus Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consulting, steering committee with Xenon that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Xeris that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Zogenix that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Zynerba that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Korro Bio Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with NeuroPro Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory board with Receptor that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory board, consultant with Biohaven that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a advisory board, consultant with CAMP4 that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory board with Cognizance Biomarker that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Rapport Therapeutics, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory board with Sage Therpeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory Board with Third Rock Ventures that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Vida Ventures Management that is relevant to AAN interests or activities.
Cynthia L. Harden, MD (Xenon Pharmaceuticals Inc) Dr. Harden has received personal compensation for serving as an employee of Xenon Pharmaceuticals Inc.. Dr. Harden has stock in Xenon Pharmaceuticals Inc.. Dr. Harden has received intellectual property interests from a discovery or technology relating to health care.
Roger J. Porter, MD, FAAN Dr. Porter has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Otsuka. Dr. Porter has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Xenon. Dr. Porter has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Passage Bio. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurocrine. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Longboard. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Engrail. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axonis. Dr. Porter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Xenon. Dr. Porter has received publishing royalties from a publication relating to health care. Dr. Porter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant with Epilepsy Study Consortium.
Michael A. Rogawski, MD, PhD (University of California - Davis) Dr. Rogawski has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Xenon Pharmaceuticals.
Emilio Perucca Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Arvelle. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GW . Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi . Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Angelini. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zogenix. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shackelford. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SKB Life Sciences. The institution of Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Xenon. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eisai. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Arvelle. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Zogenix. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Angelini. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for PMI Life Sciences. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Chiesi. Emilio Perucca has received publishing royalties from a publication relating to health care. Emilio Perucca has received publishing royalties from a publication relating to health care. Emilio Perucca has received publishing royalties from a publication relating to health care.
Martin Brodie Martin Brodie has nothing to disclose.
Gregory N. Beatch, PhD Dr. Beatch has received personal compensation for serving as an employee of Xenon Pharmaceuticals Inc. Dr. Beatch has stock in Xenon Pharmaceuticals Inc. Dr. Beatch has received intellectual property interests from a discovery or technology relating to health care.
Constanza Luzon Constanza Luzon has received personal compensation for serving as an employee of Xenon Pharmaceuticals Inc.. Constanza Luzon has stock in Xenon Pharmaceuticals.
Jenny Qian Ms. Qian has received personal compensation for serving as an employee of Xenon Pharmaceuticals.
Christopher Kenney Christopher Kenney has received personal compensation for serving as an employee of Xenon Pharmaceuticals.